Walk-in || Regulatory Affairs Executive
Pharmazone · Ahmedabad · onsite · Posted 72d ago
About a minute. You'll make an account on the way through.
About this role
- Providing the support to regulatory affairs team at Pharmazone as Senior Executive.
- Timelines management and delivery of the project.
- Looking after Documentation of the regulatory affairs department.
- Technical review of documents of products received from client for registration purpose.
- Undergoing Gap analysis of documents/data required for dossier preparation.
- Drafting and review of dossier for drug substance, drug product and administrative sections
- To update regulatory guidelines knowledge database regularly.
- Work together with cross-functional teams to ensure regulatory requirements are met throughout the dossier submission and product lifecycle management
- Prepare & review the responses for deficiency letters received from health authorities during the evaluation of marketing authorization/drug registration procedures.
- Perform regulatory submission procedures for US (ANDA), Europe, and other ROW markets.
Sourced from naukri
Skills
About Pharmazone
Pharmazone
51-200
employees
2009
17 years old
Ahmedabad, Gujarat
India
₹4.8L PA avg
Avg at Pharmazone
About
Pharmazone is a leading Consulting company with a strong legacy of trust amongst the global Pharmaceutical & Life Sciences industry. The company specializes in Regulatory Affairs, Pharmacovigilance, GxP Compliance solutions to clients for improving patient’s lives through unique Commit-Collaborate-Carry Model.
As a Regulatory Specialist, we assist our clients with solutions like Regulatory Intelligence & Strategy, Medical Writing, Submission & Publishing, Artwork, Labelling, translation, Health Authority interactions, and all post-approval requirements including an end to end Pharmacovigilance services like case management, Aggregate Reports, Signal Detection, MICC, etc. Our objective is to help large, medium & small-size life science companies in efficient execution & compliance of their drug development plans and Post-Approval Requirements for regulated markets and the developing world.
Global Regulatory Landscape is dynamic and our compliance services (GXP) play a vital role for clients. Being a trendsetter in GCP Auditing & Consulting, Pharmazone has successfully carried out 2000+ projects for Clinical Monitoring (Bioequivalence, Late Phase), Study Design, Audits, CRO setup & Up-gradation & Programme Management. Our GMP Solutions include Audits, Report Library, Quality Consulting, USFDA/EMA/PICS/WHO accreditation Support, CSV & Engineering Services including Plant Setup & Upgradation.
Though Client's trust is our biggest recognition, our hard work-filled journey has brought us various awards like "Best HealthCare Brand" by CMO Asia -ABP News, “Top 10 Clinical Research Provider” by Silicon India.
"Value Creation by Right Solutions” is Working Mantra at Pharmazone. The expert team at our global locations (INDIA, USA, EUROPE, CANADA and CHINA) have served 450+ Clients to satisfaction and we look forward to serving you!
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Culture
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Career growth
2.4
Work-life
3.0
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